Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder: Results from a prospective European multicenter study
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Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder : Results from a prospective European multicenter study. / Hardt, Stefan E; Eicken, Andreas; Berger, Felix; Schubert, Stephan; Carminati, Mario; Butera, Gianfranco; Grohmann, Jochen; Höhn, Rene; Nielsen-Kudsk, Jens Erik; Hildick-Smith, David; Settergren, Magnus; Thomson, John D; Geis, Nicolas; Søndergaard, Lars.
I: Catheterization and Cardiovascular Interventions, Bind 90, Nr. 5, 01.11.2017, s. 824-829.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder
T2 - Results from a prospective European multicenter study
AU - Hardt, Stefan E
AU - Eicken, Andreas
AU - Berger, Felix
AU - Schubert, Stephan
AU - Carminati, Mario
AU - Butera, Gianfranco
AU - Grohmann, Jochen
AU - Höhn, Rene
AU - Nielsen-Kudsk, Jens Erik
AU - Hildick-Smith, David
AU - Settergren, Magnus
AU - Thomson, John D
AU - Geis, Nicolas
AU - Søndergaard, Lars
N1 - © 2017 Wiley Periodicals, Inc.
PY - 2017/11/1
Y1 - 2017/11/1
N2 - AIMS: The GORE® CARDIOFORM Septal Occluder (GSO) is a novel device designed for rapid and effective closure of patent foramen ovale (PFO) which has distinctive features making it suitable for a broad spectrum of anatomical variations. We report the procedural and 6 months follow-up results of the first prospective, multicenter study using GSO.METHODS AND RESULTS: This single-arm study included 150 subjects undergoing closure of PFO in 10 European centers. In 149 out of 150 patients implantation of a GSO device was successful. One patient had a different PFO-closure device implanted. Periprocedural complications were few including one patient with suspected transient ischemic attack, two access site bleedings, and one patient with AV-fistula. No device embolization occurred. During the 6-month follow-up period one patient had a transient asymptomatic thrombus on the device and four patients (2.6%) were diagnosed new onset paroxysmal atrial fibrillation, which were successfully treated. No thrombembolic events occurred. Closure was successful in 94.2% of subjects at discharge evaluation and 96.9% at 6 months follow-up.CONCLUSION: This prospective, multicenter study adds to previous published data and suggests that GSO is a versatile device for PFO closure with high procedural and closure success rates and low complication rates through mid-term follow-up. © 2017 Wiley Periodicals, Inc.
AB - AIMS: The GORE® CARDIOFORM Septal Occluder (GSO) is a novel device designed for rapid and effective closure of patent foramen ovale (PFO) which has distinctive features making it suitable for a broad spectrum of anatomical variations. We report the procedural and 6 months follow-up results of the first prospective, multicenter study using GSO.METHODS AND RESULTS: This single-arm study included 150 subjects undergoing closure of PFO in 10 European centers. In 149 out of 150 patients implantation of a GSO device was successful. One patient had a different PFO-closure device implanted. Periprocedural complications were few including one patient with suspected transient ischemic attack, two access site bleedings, and one patient with AV-fistula. No device embolization occurred. During the 6-month follow-up period one patient had a transient asymptomatic thrombus on the device and four patients (2.6%) were diagnosed new onset paroxysmal atrial fibrillation, which were successfully treated. No thrombembolic events occurred. Closure was successful in 94.2% of subjects at discharge evaluation and 96.9% at 6 months follow-up.CONCLUSION: This prospective, multicenter study adds to previous published data and suggests that GSO is a versatile device for PFO closure with high procedural and closure success rates and low complication rates through mid-term follow-up. © 2017 Wiley Periodicals, Inc.
U2 - 10.1002/ccd.26993
DO - 10.1002/ccd.26993
M3 - Journal article
C2 - 28296023
VL - 90
SP - 824
EP - 829
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
SN - 1522-1946
IS - 5
ER -
ID: 195038105